- ClinicalTrials.gov ID: NCT06080074
- Not accepting healthy volunteers
- UTSW Principal Investigator: SIRINE BALTAGI
summary
The overall study design is a prospective clinical trial that combines two individual study designs into one common protocol. A. Cardiohelp Observational Trial: A prospective, multicenter clinical trial to evaluate the safety and effectiveness of the Cardiohelp system relative to a set of key performance goals (PG) derived from the ECMO literature to support FDA clearance of the Cardiohelp system as a Class II Device with special controls in accordance with the Final Order on ECMO. The trial will have an independent Data Coordinating Center (Boston Children[Single Quote]s Hospital), i.e., a non-enrolling site. B. Anticoagulation Randomized Trial: A phase II, open-label, multicenter 1:1 randomized trial to evaluate the initial safety and efficacy of UFH vs. bivalirudin as the primary anticoagulant for children on ECMO. Run-in cohort: at least one but not more than 2 patients at each site will be enrolled in a non-randomized run-in cohort using the anticoagulant of choice at each site. The remaining patients(approximately 44) in the trial will be randomized to anticoagulant. Once at least one run-in patient has been enrolled at each site, the DCC will open the randomized cohort at each site.
objective
The primary objective of this clinical trial is to evaluate safety and effectiveness of the Cardiohelp ECMO system to provide up to 30 days of circulatory support to children with severe cardiac failure where all other treatment options have failed, and clinical deterioration is expected, or risk of death is imminent. Data generated from the trial will be used to support FDA clearance of the Cardiohelp system in children under the 510(K) regulation with special controls in accordance with the Final Order on ECMO (2016). A secondary objective is to evaluate the initial safety and effectiveness of bivalirudin vs. unfractionated heparin (UFH) as the primary anticoagulant for children on ECMO who are supported with the Cardiohelp system.